浅谈我国药品抽验工作的科学化与规范化

Discussion on Drug Sampling for Assay in a Scientific and Standardized Way in China

本文结合当前药品生产、经营、使用中影响药品质量的各种环节,提出了一套药品抽验的科学计划、措施与办法。经实践应用,落实了各级药政药检的分量范围与职责;密切了执法单位与守法单位的配合协作关系;降低了不合格药品的漏检率;提高了药品抽验质量与效率;保障了人民用药安全。

Based on the existing problems affecting drug quality in the links of production,circulation and use, an integrated and scientifically designed scheme of drug sampling for assay was put forward. Having put it into practice, we found the following results:defining the limits and responsibilities of institutes of drug control at different levels in sampling drugs for assay; building closer relation between executive organs and units subjected to supervision; reducing the rate of unqualified drugs left out of supervision; raising the working quality and efficiency of drug sampling for assay;and safeguarding the security of drug use.